Lumen-measuring devices and method

ABSTRACT

The present invention provides a lumen measuring device and method that allows the user to calculate the exact length and diameter of a suitable interventional prosthesis as well as the height and length of stenosis during the same exploratory procedure.

FIELD OF THE INVENTION

The present invention relates to measurement devices and methods andmore particularly, to devices and methods of measuring the internaldiameter of a lumen of a patient and the dimensions of luminalimperfection.

BACKGROUND OF THE INVENTION

Physicians involved in therapy in general and interventional cardiologyand interventional radiology in particular have been attempting to finda way to deal with occluded (so called “stenotic”) coronary arteries(among other blood vessels, various tubular conduits and similarstructures). Additionally, the vessel diameter, as often measured usingelectronic calipers (‘imaging’ mode), and the frequency shift (‘Doppler’mode) are of prime importance in determining the mean flow rate througha vessel and both must be accurately known. Unfortunately, methods ofobtaining essential luminal dimensions have diverged based on inquiry;the physicians interested in interventional treatment of stenosis haveapproached the problem differently than those interested in determiningmean flow rate through a vessel.

Interventional radiologists interested in treatment of stenosis havefocused attention principally on the topology of the stenosis almost tothe exclusion of other important factors. Of principal importance is theidentification of stent length as a risk factor for restenosis. Theusual method of choosing stent size relies on visual estimation from theangiogram. Like many practitioners interested in this area the goal hasbeen to assess the value of an objective means of determining stentlength. In one instance, a calibrated guide wire (ATW Marker wire;Cordis) is used as a measurement tool. J. P. Reilly et al. Use of ATWMarker Wire to Guide Choice of Stent Length, Am J Cardiol 2001; 88(suppl 5A).

The theory behind this and other studies is that choice of appropriateendoluminal revascularization device (e.g., balloon angioplasty,atherectomy, laser recanalization, stents, etc) is a function ofstenosis topology. Though excessive length of endoluminalrevascularization devices can lead to migration and restenosis, aprincipal limitation of this analysis is that there are equallyimportant risk factors associated with vessel diameter. Manypractitioners pay more care in determining appropriate stent length thanexpanded stent diameter. As a rule of thumb, physicians generally employa stent that is one to two sizes larger than the estimated lumendiameter. This practice in and of itself can lead to tissue granulationand further vessel damage.

Practitioners interested in hemodynamics or patency of vessels, definedas continued flow through the treated segment, not necessarily theabsence of recurrent stenosis, use alternative tools to measure lumendiameter for purposes of determining the extent of flow there through.Most frequently, imaging tests such as CT Scans are used to assist withdimensional calculations. As a result, no apparatus has been developedthat allows for accurate in situ measurement of treated or target tissuefor purposes of evaluating patency and/or providing interventionalprosthesis.

Therefore, there is an existing need for an accurate method of measuringboth stenosis topography as well as luminal dimensions so that theprecise interventional prosthesis may be employed. In particular, thereis a need for a single device that can measure the width and height of astenosis while also measuring the diameter of lumen at both healthy andstenotic regions.

SUMMARY OF EXEMPLARY EMBODIMENTS

It is a principal object in accordance with the present invention toprovide a device capable of measuring the topology of a stenosis. In thefurtherance of this and other objectives, a preferred embodiment of thepresent invention provides a measuring means that is disposable about,distal and proximal a stenosis for measuring the dimensions of thetissue in those locations.

Yet another objective in accordance with a preferred embodiment of thepresent invention is to provide a device that is suitable for measuringthe working diameter of both healthy and diseased lumen for purposes ofaccurately determining the dimensions of an appropriate interventionalprosthesis.

Still another objective of a preferred embodiment in accordance with thepresent invention is to provide a lumen measuring device and method thatallows the user to calculate the exact length and diameter of a suitableinterventional prosthesis as well as the height and length of stenosisduring the same exploratory procedure.

It is another objective in accordance with the present invention toprovide a lumen-measuring device configured to be introduced into theworking channel of a suitable anatomically correct optical scope. In thefurtherance of this and other objectives, and provided by way of nonlimiting example only, a device in accordance with the present inventionthat is used for nonvascular indications in general and pulmonaryindications in particular may be suitably configured for use in theworking channel of a bronchoscope. It is envisioned that the opticalinstrument chosen will be a function of the general vascular/nonvasculardecision, anatomical location, and physician preference.

Further objectives, features and advantages of the invention will beapparent from the following detailed description taken in conjunctionwith the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an aerial perspective view of an exemplary lumen-measuringdelivery device in accordance with the present invention;

FIG. 2 is a side cross sectional view of an exemplary lumen deliverydevice of FIG. 1, along lines 2-2;

FIG. 3 is a side perspective view of the lumen-measuring device of FIG.1, showing a measurement indicator through the exterior lumen;

FIG. 4 is a bottom cross sectional view of the lumen-measuring device ofFIG. 3, along lines 4-4;

FIG. 5 is an aerial perspective view of an exemplary lumen-measuringdelivery device in accordance with the present invention, showing themeasurement assembly distally extended;

FIG. 6 is a side cross sectional view of an exemplary lumen deliverydevice of FIG. 5, along lines 6-6;

FIG. 7 is a side perspective view of the lumen-measuring device of FIG.5, showing a measurement indicator through the exterior lumen;

FIG. 8 is a bottom cross sectional view of the lumen-measuring device ofFIG. 7, along lines 8-8;

FIG. 9 is a cross sectional view of the legs of the measurement assemblyin a closed configuration inside the exterior conduit;

FIG. 10 is a perspective view of the measurement assembly showing thelegs in an open configuration, as shown along lines 10-10 of FIG. 6:

FIG. 11 is a cross sectional view of the distal region of the exteriorconduit showing how the detent or lip of the exterior conduit interactswith the corresponding measurement markers on the measurement assemblylegs, along lines 11-11;

FIG. 12 shows a perspective view of the lumen-measuring device of FIG.1, showing the measurement assembly in the closed configuration asviewed from the distal tip thereof;

FIG. 13 is a perspective view of the lumen-measuring device of FIG. 1,showing the measurement assembly in the open configuration as viewedfrom the distal tip thereof;

FIG. 14 is a side perspective view of the closed measurementconfiguration of the alternative lumen-measuring device embodiment ofFIG. 14 showing a measurement indicator through the exterior lumen;

FIG. 15 is a bottom perspective view of the alternative lumen-measuringdevice of FIG. 14, showing the legs in the closed measuringconfiguration;

FIG. 16 is a side perspective view of an open measurement configurationof an alternative lumen-measuring device embodiment showing ameasurement indicator through the exterior lumen;

FIG. 17 is a bottom perspective view of the alternative lumen-measuringdevice of FIG. 14, showing the legs in the open measuring configuration;

FIG. 18 is a side perspective view of the measurement assembly of thealternative lumen-measuring device of FIG. 14, showing the legs in theopen measuring configuration;

FIG. 19 is a side perspective view of an exemplary lumen-measuringdevice, wherein the measurement assembly comprises a dilation balloon, adiameter measurement balloon and measurement markers.

FIG. 20 is a cross sectional view of the lumen-measuring device of FIG.19, showing the internal conduits, that feed the respective balloons,along lines 20-20;

FIG. 21 is a perspective view of the measuring portion of thelumen-measuring device of FIG. 19, showing the measurement markers onthe dilation balloon in the uninflated configuration;

FIG. 22 is a side view of the measuring portion of the lumen-measuringdevice of FIG. 19, showing the measurement markers on the dilationballoon in the uninflated;

FIG. 23 is a perspective view of the measuring portion of thelumen-measuring device of FIG. 19, showing the measurement markers onthe diameter measurement balloon in the inflated configuration;

FIG. 24 is a side view of the measuring portion of the lumen-measuringdevice of FIG. 19, showing the measurement markers on the diametermeasurement balloon in the inflated;

FIG. 25 is a perspective view of the measuring portion of thelumen-measuring device of FIG. 19, showing the measurement markers onthe dilation and diameter measurement balloons in the inflatedconfiguration;

FIG. 26 is a side view of the measuring portion of the lumen-measuringdevice of FIG. 19, showing the measurement markers on the dilation anddiameter measurement balloons in the inflated;

FIG. 27 is a perspective view of an exemplary lumen-measuring device ofFIG. 19, indicated for nonvascular lumen, showing the lumen-measuringdevice disposed within the working channel of a bronchoscope, whereinthe measurement assembly comprises a dilation balloon about a stenosis,a diameter measurement balloon which is in the inflated configurationand measurement markers;

FIG. 28 is a side view of an exemplary lumen-measuring device of FIG.19, indicated for nonvascular lumen, showing the lumen-measuring devicedisposed within the working channel of a bronchoscope, wherein themeasurement assembly comprises a dilation balloon about a stenosis, adiameter measurement balloon which is in the inflated configuration andmeasurement markers;

FIG. 29 is a cross sectional view of the co-extruded conduits, of FIG.20, showing an inflation channel along lines 29-29; and

FIG. 30 is a side cross sectional view of the co-extruded conduits, ofFIG. 20, showing an inflation channel along lines 30-30.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

A preferred embodiment in accordance with the present invention providesa lumen measuring device and method that allows the user to calculatethe exact length and diameter of a suitable interventional prosthesis aswell as the height and length of stenosis during the same exploratoryprocedure. In the furtherance of this and other objectives, an exemplarydevice is capable of measuring the topology of a stenosis by providing ameasuring means that is disposable about, distal and proximal a stenosisfor measuring the dimensions of the tissue in those locations. Moreover,the device is suitable for measuring the working diameter of bothhealthy and diseased lumen for purposes of accurately determining thedimensions of an appropriate interventional prosthesis.

The device is capable of being introduced into the working channel of asuitable anatomically correct optical scope. For example, a device inaccordance with the present invention that is used for nonvascularindications in general and pulmonary indications in particular may besuitably configured for use in the working channel of a bronchoscope. Asdiscussed above, the optical instrument chosen will be a function of thegeneral vascular/nonvascular decision, anatomical location, andphysician preference.

Now making specific reference to the Figures where like numerals refersto like components, a lumen-measuring device is provided to give moreaccurate lumen dimensional information for purposes of interventionaltreatment. In particular, a lumen-measuring device 100 is providedgenerally in FIGS. 1-13.

In a preferred embodiment, the lumen-measuring device 100 comprises aplurality of conduits longitudinally extending between proximal anddistal ends, namely exterior 130 and interior 180 conduits, the exteriorconduit 130 is coupled with a handle 220 at the proximal end and ameasurement assembly 240 at the distal end. The handle 220 and themeasurement assembly 240 being operatively connected with one anothervia the interior conduit 180 at the interior conduit's proximal 190 anddistal ends 200, respectively. The interior conduit 180 also has a depthmarking mechanism 210 visible through the proximal region of theexterior conduit 140. The handle 220 provides a trigger mechanism 230that allows the user to place the measurement assembly 240 in an open orclosed configuration by pushing or pulling the trigger mechanism 230.The trigger 230 is preferably a slide-gauged mechanism but may be anynumber of alternative guiding systems known in the art. In the slidegauge embodiment, when the trigger mechanism 230 is pushed in a distaldirection with respect to the handle 220, the interior conduit 180 urgesthe measurement assembly 240 distal the exterior conduit 130 causing themeasurement assembly 240 to open. Retracting the trigger mechanism 230in a proximal direction with respect to the handle 220 closes themeasurement assembly 230.

The measurement assembly 230 comprises at least two legs 250, 300 havingdistal 260, 310 and proximal ends 270, 320 and inward facing 280, 330and lumen facing 290, 340 surfaces, the legs are preferably coupled witheach other at their respective proximal ends 270, 320. Distal the pointat which the legs 250, 300 are coupled, the legs 250, 300 are designedto diverge from one another when unconstrained. In the furtherance ofthis objective, the legs 250, 300 are preferably formed of a shapememory alloy such as nitinol so that when the legs are constrained bythe exterior conduit 130 they lay substantially flush with respect toone another but diverge when the exterior conduit 130 is evacuated.

Additional legs may be employed so that the topology of the lumen 570may be assessed from varying perspectives. In a preferred embodiment,four legs are provided. Each leg is provided with measurement markers350 that are disposed at predetermined intervals between the distal andproximal ends of each leg. Accuracy and corresponding leg dimensionalmeasurements can be confirmed and calibrated by providing thelumen-measuring device 100 into a vessel with known interior dimensions.The legs are then urged distally until the distal ends of the legs touchthe interior surface of the vessel. Since the interior dimensions of thevessel are known, it is easy to calibrate the measuring device so thatthe measurement markers correspond to the known dimensions.

As an added feature to ensure accuracy, preferred embodiments of thepresent device provide legs that have measurement markers 350 that arecarved into the legs so as to form detent or lip catches 360. Dependingon the embodiment described, markers 350 and lip catches 360 may be usedinterchangeably as one or both may be present in the same location. Theexterior conduit 130 has corresponding detents 170 or a lip 170 aboutthe distal end 150 thereof to ensure that the legs do not overshoot themaximum lumen measurement and damage the lumen tissue. Moreover, onlymoderate distal force is necessary to urge the legs beyond the lip 170,however, once the proper extension has been achieved, this featureallows the measuring assembly to remain stable until the calculation hasbeen made.

Referring now to FIGS. 14-18, in an alternative embodiment, instead ofthe distal ends of the legs making independent contact with the lumensurface, the distal ends are coupled together so that measurement takesplace proximal the distal ends of the legs. In this embodiment, themeasurement assembly takes on the configuration of a whisk, wherein theexterior diameter at the distal and proximal ends, when if fullyextended, is significantly smaller relative to the measurement portionthere between. However, when the measurement assembly is retracted, thelegs are relaxed and reside adjacent one another so that the legs may beretracted within the exterior conduit.

In this and other related embodiments, the exterior conduit hasmeasurement markers 160 formed thereon. Additionally, the lumen facingsurfaces 280, 330 of the measurement assembly 240 legs have measurementmarkers 350 and/or 360 formed thereon. As the trigger mechanism 230 ispushed distally, the measurement assembly 240 moves distal the distalend 150 of the exterior conduit 130 and begins to separate the legs ofthe measurement assembly 240 with respect to one another. The furtherthe trigger mechanisms 230 is pushed in the distal directions, thefurther the legs open and the greater the number of measurement markings350 and/or 360 on the measurement assembly 240 extended beyond thedistal end 150 of the exterior conduit 130. In a preferred embodiment,the distal end 150 of the exterior conduit 130 have inward facingdetents or lip 170 that are complementary to the measurement markers 350and/or 360 on the measurement assembly 240. At each measurement marking350, the detent or lip 170 may be engaged by they detent catches 360 ofthe measurement marker 350 to prevent overshooting the target. Once thelegs have been opened until the distal ends of the legs of themeasurement assembly 240 are in contact with the tissue to be measured,the user need only count the measurement markings 350 to determine thedesired dimensions of the target tissue.

In order to determine the length of the target tissue, the user needonly open the measurement assembly 240 just proximal and just distal thetarget tissue, in no particular order and note the distances between thetwo locations on the depth marking mechanism 210 of the interior conduit180, which is preferably just distal the handle 220.

An alternative embodiment of the present invention, as shownspecifically in FIGS. 19-30 comprises a flexible device 420 withpreferably two balloons and three conduits—one conduit for each balloonand one that goes all the way through. The bottom balloon issubstantially flat and round and is referred to generally as thediameter measurement balloon 480; the upper balloon is longer and narrowand is referred to generally as the dilation balloon 430. The firstconduit 520 preferably inflates the diameter measurement diametermeasurement balloon 470 and the second conduit 550 inflates the dilationballoon 430. The third conduit 560, which preferably terminates at thedistal end tip 540, principally serves a delivery and measurementfunction. In a preferred embodiment, the outermost conduit 520 hasmeasurement markings 530 that are visible from the interior and/or theexterior thereof.

The diameter measurement balloon 470 has substantially flat distal 480and proximal 490 surfaces, with a substantially circular edge 500 therebetween, resulting in a hollow pancake shaped configuration. In apreferred embodiment, the diameter measurement balloon 470 has diametermeasurement marker 510 of varying colors on the proximal and/or distalsurface thereof to form a target like representation. Alternatively, thedilation balloon 430 has a substantially cylindrical shape with proximal450 and distal ends 440 coupled along the outermost conduit 520.

When the pre-sterilized device is initially installed the diametermeasurement balloon 470 is compressed proximal the distal tip 540 of theoutermost conduit 520 and the dilation balloon 430 is compressed aboutthe outermost conduit 520, proximal the diameter measurement balloon470. In this configuration, as specifically shown in FIGS. 27-28, thedevice is easily delivered to the target site. When used to evaluatestenotic tissue, the tip 540 is preferably positioned distal thestenosis 580 such that the diameter measurement balloon is placed justdistal the stenosis. The diameter measurement balloon 470 is theninflated sufficiently to allow it to sit flush with the inner diameterof the subject lumen 570 or stenosis 580.

Through the use of visualization means, such as optical instruments likea bronchoscope 110, the topology of the stenosis 580 can be directlyviewed. The diameter measurement balloon 470 is preferably designed withdiameter measurement markers 510 formed on the proximal face thereof toallow the user to visually measure the extent of luminal occlusion basedon the number of diameter measurement markers covered by the stenosis580 when viewing the diameter measurement balloon 470 from a positionproximal the stenosis 580. Furthermore, this allows the physician to seeif the stenosis 580, or other observed occlusion, is symmetrical, etc.

Simultaneously, the physician may observe the measurement markers 460,510 visible through the outermost conduit 520 to see the dimensions ofthe occlusion from end-to-end or from specific points. Additionally, thedilation balloon 430 may also be inflated to serve as an additionalmeasurement of the working diameter of the diseased lumen 570. To thisend, the dilation balloon 430 is inflated until it substantially closesthe diseased portion of the lumen 570.

Based on the measurements collected from this simple and inexpensiveprocedure, an interventional prosthesis may be selected, if necessary,that is appropriate in length and diameter so as to prevent furtherdamage to the target lumen while providing sufficient outward radialsupport.

In this and other embodiments that employ balloons, a predetermined airpressure is provided to each balloon and each balloon conduit may beconfigured with a pressure manometer.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrative,and not restrictive. The scope of the invention is, therefore, indicatedby the appended claims, rather than by the foregoing description. Allchanges, which come within the meaning and range of equivalency of theclaims, are to be embraced within their scope.

1. A device that allows a user to calculate the length and diameter of asuitable interventional prosthesis as well as the height and length ofstenosis during the same exploratory procedure, the device comprising:an exterior conduit longitudinally extending between proximal and distalends, the exterior conduit having measurement markers formed on aportion thereof; an interior conduit longitudinally extending betweenproximal and distal ends, disposed within the exterior conduit, anddisplaceable with respect to the exterior conduit, the interior conduithaving a depth marking mechanism visible through a portion of theexterior conduit; a measurement assembly comprising at least two legshaving distal and proximal ends and inward facing and lumen facingsurfaces, the legs coupled with each other proximal the distal endsthereof, the measurement assembly also coupled about the distal end ofthe interior conduit; a handle operatively connected with themeasurement assembly, the handle comprising a means for opening andclosing the measurement assembly by actuating the handle along acontinuum between a first closed configuration and a second openconfiguration.
 2. The device of claim 1, wherein the inward facingsurfaces of the legs are substantially flush with one another when themeasurement assembly is closed.
 3. The device of claim 2, wherein whenthe measurement assembly is moved distally in relation to the firstconduit, the legs form an acute angle with respect to one another. 4.The device of claim 3, wherein the measurement assembly furthercomprises a third leg.
 5. The device of claim 1, wherein the distal endsof the legs are coupled together, wherein measurement of the target sitetakes place between the distal and proximal ends thereof.
 6. The deviceof claim 1, wherein the handle further comprises a measurementindicator, wherein target lumen dimensions are calculated based on therelative distance the handle travels along the continuum between thefirst and second handle locations.
 7. A method of measuring a targetsegment of a lumen of a patient so as to select a suitableinterventional prosthesis, the method comprising: providing a measuringdevice having an exterior conduit longitudinally extending betweenproximal and distal ends, the exterior conduit having measurementmarkers formed on a portion thereof; an interior conduit longitudinallyextending between proximal and distal ends, disposed within the exteriorconduit, and displaceable with respect to the exterior conduit, theinterior conduit having a depth marking mechanism visible through aportion of the exterior conduit; a measurement assembly comprising atleast two legs having distal and proximal ends and inward facing andlumen facing surfaces, the legs coupled with each other proximal thedistal ends thereof, the measurement assembly also coupled about thedistal end of the interior conduit; a handle operatively connected withthe measurement assembly, the handle comprising a means for opening andclosing the measurement assembly by actuating the handle along acontinuum between a first closed configuration and a second openconfiguration; introducing the device into an appropriate anatomicalorifice of a patient; delivering the device adjacent a target segment ofa lumen within the patient; and measuring the length of the targetsegment of the lumen within the patient.
 8. The method of claim 7,wherein the device further comprises an optical scope operativelycoupled therewith, such that the measuring step is accomplished usingthe optical scope.
 9. The method of claim 7, wherein the inward facingsurfaces of the legs are substantially flush with one another when themeasurement assembly is closed.
 10. The method of claim 9, wherein whenthe measurement assembly is moved distally in relation to the firstconduit, the legs form an acute angle with respect to one another. 11.The method of claim 10, wherein the measurement assembly furthercomprises a third leg.
 12. The method of claim 7, wherein the distalends of the legs are coupled together, wherein measurement of the targetsite takes place between the distal and proximal ends thereof.
 13. Themethod of claim 7, wherein the handle further comprises a measurementindicator, wherein target lumen dimensions are calculated based on therelative distance the handle travels along the continuum between thefirst and second handle locations.
 14. The method of claim 7, furthercomprising the step of measuring the diameter of the target segment ofthe lumen within the patient.
 15. The method of claim 14, wherein thediameter measuring step comprises the step of actuating the handle alongthe continuum from the first closed configuration toward the second openconfiguration until the legs of the measurement mechanism come incontact with the target segment of the lumen and calculating the lengthas a function of the number of leg measurement markings distal theexterior conduit.
 16. The method of claim 14, wherein the target segmentof the lumen is stenotic.
 17. The method of claim 7, wherein the devicefurther comprises an optical scope operatively coupled therewith, suchthat the measuring step is accomplished using the optical scope.
 18. Themethod of claim 16, further comprising the step of measuring the lengthof the stenosis.
 19. The method of claim 18, wherein the delivering stepfurther comprises the step of positioning the distal end of the firstconduit distal the stenosis.
 20. The method of claim 19, wherein themeasurement mechanism is opened and placed distal the stenosis such thatthe exterior conduit is retracted and the stenosis length measurement isa function of the distance the exterior conduit is retracted proximally.21. The method of claim 18, wherein the stenosis length measuring stepcomprises the step of actuating the handle along the continuum from thefirst closed configuration toward the second open configuration untilthe legs of the measurement mechanism come in contact with the targetsegment of the lumen and calculating the length as a function of thedistance between the first handle position and the current point of thehandle along the continuum.
 22. The method of claim 16, furthercomprising the step of measuring the height of the stenosis.
 23. Themethod of claim 22, further comprising the step of measuring the lengthof the stenosis.
 24. A method of measuring a target segment of a lumenof a patient so as to select a suitable interventional prosthesis, themethod comprising: providing a measuring device having an exteriorconduit longitudinally extending between proximal and distal ends, theexterior conduit having measurement markers formed on a portion thereof;an interior conduit longitudinally extending between proximal and distalends, disposed within the exterior conduit, and displaceable withrespect to the exterior conduit, the interior conduit having a depthmarking mechanism visible through a portion of the exterior conduit; ameasurement assembly comprising four legs having distal and proximalends and inward facing and lumen facing surfaces, the legs coupled witheach other proximal the distal ends thereof, the measurement assemblyalso coupled about the distal end of the interior conduit; a handleoperatively connected with the measurement assembly, the handlecomprising a means for opening and closing the measurement assembly byactuating the handle along a continuum between a first closedconfiguration and a second open configuration; introducing the deviceinto an appropriate anatomical orifice of a patient; delivering thedevice adjacent a target segment of a lumen within the patient; andmeasuring the diameter of the target segment of the lumen within thepatient.
 25. A device that allows a user to calculate the length anddiameter of a suitable interventional prosthesis as well as the heightand length of stenosis during the same exploratory procedure, the devicecomprising: a diameter measurement balloon comprising substantially flatdistal and proximal surfaces, with a substantially circular edge therebetween, the diameter measuring balloon having diameter measurementmarkers on the proximal and/or distal surface thereof; a dilationballoon that has a substantially cylindrical shape with proximal anddistal ends; a plurality of conduits, a diameter measurement conduit forinflating the diameter measurement balloon, a dilation conduit forinflating the dilation balloon and an outermost conduit, the outermostconduit having proximal and distal ends and measurement markings therebetween, the diameter measurement conduit and the dilation conduitdisposed within the outermost conduit such that the dilation balloon andthe diameter measurement balloon are coupled along the outermost conduityet operatively coupled with the dilation and measurement conduits,respectively through the outermost conduit.
 26. The device of claim 25,wherein the plurality of conduits are co-extruded.
 27. A method ofmeasuring a target segment of a lumen of a patient so as to select asuitable interventional prosthesis, the method comprising: providing ameasuring device having a diameter measurement balloon comprising asubstantially flat distal and proximal surfaces, with a substantiallycircular edge there between, the diameter measuring balloon havingdiameter measurement markers on the proximal and/or distal surfacethereof; a dilation balloon that has a substantially cylindrical shapewith proximal and distal ends; a plurality of conduits, a diametermeasurement conduit for inflating the diameter measurement balloon, adilation conduit for inflating the dilation balloon and an outermostconduit, the outermost conduit having proximal and distal ends andmeasurement markings there between, the diameter measurement conduit andthe dilation conduit disposed within the outermost conduit such that thedilation balloon and the diameter measurement balloon are coupled alongthe outermost conduit yet operatively coupled with the dilation andmeasurement conduits, respectively through the outermost conduit;introducing the device into an appropriate anatomical orifice of apatient; delivering the device adjacent a target segment of a lumenwithin the patient; and measuring the specific dimensions of the targetsegment of the lumen within the patient.
 28. The method of claim 27,wherein the device further comprises an optical scope operativelycoupled therewith, such that the measuring step is accomplished usingthe optical scope.
 29. The method of claim 27, wherein the targetsegment of the lumen is stenotic.
 30. The method of claim 29, whereinthe specific dimensions of the target segment is selected from the groupconsisting of length, height, circumference, radius, diameter andcombinations thereof.
 31. A device that allows a user to calculate thelength and diameter of a suitable interventional prosthesis as well asthe height and length of stenosis during the same exploratory procedure,the device comprising: a diameter measurement balloon comprisingsubstantially flat distal and proximal surfaces, with a substantiallycircular edge there between, the diameter measuring balloon havingdiameter measurement markers on the proximal and/or distal surfacethereof; a dilation balloon that has a substantially cylindrical shapewith proximal and distal ends; a tube having and interior and anexterior, the interior defining three apertures passing at leastpartially there through, the first aperture comprising a diametermeasurement conduit for inflating the diameter measurement balloon, thesecond aperture comprising a dilation conduit for inflating the dilationballoon and an third aperture that extends the length thereof, the thirdaperture comprising a working channel, the diameter measurement conduitand the dilation conduit disposed within the tube conduit such that thedilation balloon and the diameter measurement balloon are coupled alongthe exterior of the tube yet operatively coupled with the dilation andmeasurement conduits, respectively through the outermost conduit.
 32. Amethod of measuring a target segment of a lumen of a patient so as toselect a suitable interventional prosthesis, the method comprising:providing a measuring device having a diameter measurement ballooncomprising a substantially flat distal and proximal surfaces, with asubstantially circular edge there between, the diameter measuringballoon having diameter measurement markers on the proximal and/ordistal surface thereof; a dilation balloon that has a substantiallycylindrical shape with proximal and distal ends; a tube having andinterior and an exterior, the interior defining three apertures passingat least partially there through, the first aperture comprising adiameter measurement conduit for inflating the diameter measurementballoon, the second aperture comprising a dilation conduit for inflatingthe dilation balloon and an third aperture that extends the lengththereof, the third aperture comprising a working channel, the diametermeasurement conduit and the dilation conduit disposed within the tubeconduit such that the dilation balloon and the diameter measurementballoon are coupled along the exterior of the tube yet operativelycoupled with the dilation and measurement conduits, respectively throughthe outermost conduit; introducing the device into an appropriateanatomical orifice of a patient; delivering the device adjacent a targetsegment of a lumen within the patient; and measuring the specificdimensions of the target segment of the lumen within the patient. 33.The method of claim 32, wherein the device further comprises an opticalscope operatively coupled therewith, such that the measuring step isaccomplished using the optical scope.
 34. The method of claim 32,wherein the target segment of the lumen is stenotic.
 35. The method ofclaim 34, wherein the specific dimensions of the target segment isselected from the group consisting of length, height, circumference,radius, diameter and combinations thereof.
 36. The device of claim 35,wherein the tube further comprises proximal and distal ends andmeasurement markings there between.
 37. A device that allows a user tocalculate the length and diameter of a suitable interventionalprosthesis as well as the height and length of stenosis during the sameexploratory procedure, the device comprising: an exterior conduitlongitudinally extending between proximal and distal ends, the exteriorconduit having measurement markers formed on a portion thereof; aninterior conduit longitudinally extending between proximal and distalends, disposed within the exterior conduit, and displaceable withrespect to the exterior conduit; a measurement assembly comprising aplurality of legs having distal and proximal ends and inward facing andlumen facing surfaces, the legs coupled with each other proximal thedistal ends thereof, the measurement assembly also coupled about thedistal end of the interior conduit; a handle operatively connected withthe measurement assembly, the handle comprising a means for opening andclosing the measurement assembly by actuating the handle along acontinuum between a first closed configuration and a second openconfiguration.
 38. The device of claim 37, wherein the inward facingsurfaces of the legs are substantially flush with one another when themeasurement assembly is closed.
 39. The device of claim 38, wherein whenthe measurement assembly is moved distally in relation to the firstconduit, the legs form an acute angle with respect to one another. 40.The device of claim 39, wherein the measurement assembly comprises fourlegs.
 41. The device of claim 37, wherein the distal ends of the legsare coupled together, wherein measurement of the target site takes placebetween the distal and proximal ends thereof.
 42. The device of claim37, wherein the handle further comprises a measurement indicator,wherein target lumen dimensions are calculated based on the relativedistance the handle travels along the continuum between the first andsecond handle locations.